Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects

Randomized, Placebo-controlled Clinical Study to Evaluate the Effect of 2 Months of Nutritional Support Based on Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 (OLEP Study) on Muscle Mass in Sarcopenic Subjects

The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.

Inclusion Criteria:

• Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
• Body Mass Index between 20 and 30 Kg/m2

Exclusion Criteria:

• severe renal failure (glomerular filtration rate < 30 mL/min)
• moderate to severe liver failure (Child-Pugh class B or C)
• endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
• known psychiatric disorders
• cancer (over the past 5 years)
• hypersensitivity to any component of the investigational nutritional supplement and
• taking to protein/amino acid supplements (up to 3 months before starting the study)
• patients unable to take oral therapy
• receiving or with indication for artificial nutrition
• who had been included in another clinical nutrition trial